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Last Updated: March 3, 2021

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CLINICAL TRIALS PROFILE FOR VARESPLADIB

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Clinical Trials for Varespladib

Trial ID Title Status Sponsor Phase Summary
NCT00434473 IMPACTS Trial: Investigation of the Modulation of Phospholipase in Acute Chest Syndrome Completed Anthera Pharmaceuticals Phase 2 The study will be conducted at 15-20 US centers in a randomized, placebo-controlled, double-blind fashion. Enrollees will be hospitalized sickle cell disease (SCD) patients at-risk for acute chest syndrome (ACS) based on the presence of vaso-occlusive crisis (VOC), fever (T ≥38.0°C) and serum sPLA2 concentration ≥50 ng/mL.
NCT00533039 sPLA2 Inhibition to Decrease Enzyme Release After PCI Trial Completed Anthera Pharmaceuticals Phase 2 As evidence accumulates that atherogenesis or Coronary Artery Disease (CAD) may not be simply a disorder of lipid metabolism, but an inflammatory disease, the focus of treatment has shifted. A-002 or Varespladib is an anti-inflammatory drug for treatment of chronic and acute diseases. It acts by inhibiting secretory phospholipase A2 (sPLA2 ) - one of a family of enzymes leading to inflammation - which may be important in: 1) the development of atherosclerosis and 2) the increase in occurence of cardiovascular events after angioplasty. Previous studies have demonstrated that sPLA2: 1) facilitates the pro-atherogenic effects of low-density (LDL or bad cholesterol) and 2) increased levels post-angioplasty correlate with an increased risk of events at followup contact. Therefore this study proposes to investigate the ability of A-002 to prevent or reduce myocardial damage after angioplasty by inhibiting the cascade of inflammatory mediators. Substudy - Subjects who agree will also have a vascular ultrasound 24h post-PCI to assess endothelial function.
NCT00533039 sPLA2 Inhibition to Decrease Enzyme Release After PCI Trial Completed University Health Network, Toronto Phase 2 As evidence accumulates that atherogenesis or Coronary Artery Disease (CAD) may not be simply a disorder of lipid metabolism, but an inflammatory disease, the focus of treatment has shifted. A-002 or Varespladib is an anti-inflammatory drug for treatment of chronic and acute diseases. It acts by inhibiting secretory phospholipase A2 (sPLA2 ) - one of a family of enzymes leading to inflammation - which may be important in: 1) the development of atherosclerosis and 2) the increase in occurence of cardiovascular events after angioplasty. Previous studies have demonstrated that sPLA2: 1) facilitates the pro-atherogenic effects of low-density (LDL or bad cholesterol) and 2) increased levels post-angioplasty correlate with an increased risk of events at followup contact. Therefore this study proposes to investigate the ability of A-002 to prevent or reduce myocardial damage after angioplasty by inhibiting the cascade of inflammatory mediators. Substudy - Subjects who agree will also have a vascular ultrasound 24h post-PCI to assess endothelial function.
NCT00743925 FRANCIS-ACS Trial: A Study of the Safety and Efficacy of A 002 in Subjects With Acute Coronary Syndromes Completed Anthera Pharmaceuticals Phase 2 The objective of this study is to evaluate the safety and efficacy of A 002 when added to high dose atorvastatin in subjects with an acute coronary syndrome (ACS)
NCT01130246 VISTA-16 Trial: Evaluation of Safety and Efficacy of Short-term A-002 Treatment in Subjects With Acute Coronary Syndrome Terminated Anthera Pharmaceuticals Phase 3 The objective of this study is to evaluate the safety and efficacy of short-term A-002 treatment on morbidity and mortality when added to atorvastatin and standard of care in subjects with an acute coronary syndrome (ACS).
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for Varespladib

Condition Name

Condition Name for
Intervention Trials
Vaso-occlusive Crisis 2
Sickle Cell Disease 2
Acute Coronary Syndrome 2
Myocardial Ischemia 1
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Condition MeSH

Condition MeSH for
Intervention Trials
Syndrome 3
Acute Coronary Syndrome 2
Myocardial Ischemia 2
Anemia, Sickle Cell 2
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Clinical Trial Locations for Varespladib

Trials by Country

Trials by Country for
Location Trials
United States 42
Hungary 9
India 9
Spain 8
Australia 8
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Trials by US State

Trials by US State for
Location Trials
Georgia 3
Minnesota 2
New York 2
Virginia 2
Florida 2
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Clinical Trial Progress for Varespladib

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 3 1
Phase 2 5
Phase 1 2
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Completed 4
Terminated 3
Not yet recruiting 1
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Clinical Trial Sponsors for Varespladib

Sponsor Name

Sponsor Name for
Sponsor Trials
Anthera Pharmaceuticals 7
Shifa Tameer-e-Millat University 1
Rawalpindi Institute of Cardiology 1
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 7
Other 3
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